COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM— 510(k) K993161
Substantially EquivalentCopan Diagnostics, Inc.
FDA 510(k) clearance K993161 for COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM, Substantially Equivalent on 1999-11-09. Applicant: Copan Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Copan Diagnostics, Inc.
- Product code
- Code JTW
- Device class
- Class 1
- Regulation
- 21 CFR 866.2900
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
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More clearances from Copan Diagnostics, Inc.
view allRecalls naming K993161
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993161.
Data sourced from openFDA. This site is unofficial and independent of the FDA.